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A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

RecruitingPhase 1

Sponsor: Incyte Corporation

Conditions: Myeloproliferative Neoplasms

Interventions: INCA035784

Countries: United States, Australia, Belgium, Germany, Italy

This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age 18 years or older at the time of signing the ICF
* ECOG performance status of 0 to 1 for the dose escalation (Part 1a) and 0 to 2 for the dose expansion (Part 1b)
* Documented CALR exon-9 mutation
* Confirmed diagnosis of MPN according to the 2022 ICC criteria:

  * DIPSS+ intermediate-2/high-risk MF with prior JAKi, \<20% blasts, and measurable spleen
  * High-risk ET with platelets \>450×10⁹/L
* Resistant, refractory, intolerant, or has lost response to ≥1 prior line of therapy for MF and ≥2 prior lines for ET (unless only a single standard-of-care option is approved in the participating country)
* No prior stem cell transplant and none planned within 6 months
* Minimum Laboratory Requirements:

  * Platelet count ≥50 × 10⁹/L
  * Absolute neutrophil count ≥1 × 10⁹/L
  * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN), unless receiving vitamin K antagonists
  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5 × ULN
  * Total bilirubin \<2 × ULN
  * Estimated creatinine clearance \>45 or \>30 mL/min (depending on study part)

Exclusion Criteria:

* Major bleeding or thrombosis (e.g., stroke, DVT, PE) within the past 3 months
* Active or high-risk HBV, HCV, or HIV infection, or other chronic active infections requiring systemic treatment
* Active invasive cancer within the past 2 years, except certain early-stage or low-risk cancers (e.g., resected skin, cervical, thyroid, or prostate cancer)
* Pregnant or unwilling to avoid pregnancy or fathering a child during the study and for a defined period after the last dose.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Locations (26)

Phoenix, Arizona, United States
Palo Alto, California, United States
Denver, Colorado, United States
Jacksonville, Florida, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Austin, Texas, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Milwaukee, Wisconsin, United States
Sydney, New South Wales, Australia
Adelaide, South Australia, Australia
Melbourne, Victoria, Australia
Nedlands, Western Australia, Australia
Brussels, Belgium
Ghent, Belgium
Leuven, Belgium
Dresden, Germany
Halle, Germany
Mainz, Germany
Bergamo, Italy
Florence, Italy
Milan, Italy
Verona, Italy